Axsome Therapeutics, Inc. · NASDAQ:AXSM
Axsome Therapeutics — Investor Presentation (May 2026)
26 slides from Axsome Therapeutics's investor presentation, May 1, 2026
Slide 1: FDA Approval of AUVELITY in Agitation Associated with Dementia due to Alzheimer's Disease
FDA Approval of AUVELITY ® in Agitation Associated with Dementia due to Alzheimer’s Disease Investor Overview May 1, 2026 © Axsome Therapeutics, Inc.
Slide 2: Forward looking statements & safe harbor
Forward looking statements & safe harbor Certain matters discussed in this presentation are the Company’s ability to fund additional clinical trials to The factors discussed herein could cause actual results “forward-looking statements” . The Company may, in continue the advancement of the Company’s
Slide 3: Today's agenda
Today’s agenda Mark Jacobson, MA Introduction Chief Operating Officer Herriot Tabuteau, MD Opening Remarks Chief Executive Officer Ari Maizel Commercial Overview Chief Commercial Officer Jeffrey Cummings, MD, ScD Alzheimer’s Disease Agitation Chambers -Grundy Professor of Brain Sciences, UNLV Kirk K
Slide 4: Opening Remarks
Opening Remarks Herriot Tabuteau, MD Founder and Chief Executive Officer 4 © Axsome Therapeutics, Inc.
Slide 5: Our Mission
Our Mission Develop and deliver transformative medicines to improve the brain health of millions of individuals © Axsome Therapeutics, Inc.
Slide 6: AUVELITY: new approved indication
NEW APPROVED INDICATION AUVELITY ® For Agitation Associated with Dementia due to Alzheimer’s Disease A first -in -class treatment that targets NMDA and sigma -1 receptors 6
Slide 7: Mechanism of Alzheimer's disease agitation
Mechanism of Alzheimer’s disease agitation Changes in the brain associated Posterior cingulate with Alzheimer’s disease cortex (PCC) Anterior cingulate In Alzheimer’s disease, insoluble A β production and cortex (ACC) accumulation triggers secondary steps leading to Prefrontal 1,2 cortex (PFC) synap
Slide 8: First-in-class treatment for agitation associated with Alzheimer's disease
First -in -class treatment for agitation associated with Alzheimer’s disease Efficacy demonstrated in short -term and long -term studies • Only approved treatment for agitation associated with dementia due to Alzheimer’s disease demonstrating substantial symptom improvement and statistically signifi
Slide 9: AUVELITY highlights of prescribing information
AUVELITY highlights of prescribing information Updates for new indication highlighted in yellow INDICATIONS AND USAGE WARNINGS AND PRECAUTIONS AUVELITY is a combination of dextromethorphan, an • Seizure: Risk is dose -related. Discontinue if seizure occurs. (4, 5.2) uncompetitive N -methyl D -aspart
Slide 10: AUVELITY demonstrated significant improvement in agitation symptoms
AUVELITY demonstrated significant improvement in agitation symptoms ADVANCE -1 a,b 0 Primary endpoint: Change from baseline Bupropion SR treatment arm terminated early for futility in CMAI total score at Week 5 -2 Placebo (N=156) AUVELITY (N=152) -4 14.9 -point reduction in the CMAI total score at W
Slide 11: Sustained efficacy and relapse prevention in a long-term study
AUVELITY demonstrated sustained efficacy and relapse prevention in a long -term study ACCORD -2 40% Hazard Ratio for Time to Relapse Primary endpoint: Time from 35% randomization to relapse of agitation Hazard Ratio a 0.276 (95% CI) (0.119-0.641) 30% p-value b 0.001 72.4% Percentage of Patients redu
Slide 12: Commercial Overview
Commercial Overview Ari Maizel Chief Commercial Officer 12
Slide 13: Opportunity to advance care for a critically underserved neuropsychiatric condition
Opportunity to advance care for a critically underserved neuropsychiatric condition Alzheimer’s disease agitation Prescriber mix People in the U.S. living with >5M Alzheimer’s disease agitation PCP ~50% Patients treated with a pharmacotherapy 1 76% Psychiatry Neurology 1 Previously approved treatmen
Slide 14: Survey of care partners underscores burden of agitation symptoms
A large survey of Alzheimer’s care partners underscores the burden associated with agitation symptoms A survey of 751 care partners * sponsored by Axsome Say agitation has a negative impact on Therapeutics in partnership with a leading polling and 97% their loved one’s quality of life research surve
Slide 15: Expanding AUVELITY's reach into Alzheimer's disease agitation
Expanding AUVELITY’s reach into Alzheimer’s disease agitation FIELD FORCE EXPANSION HCP targets treating Sales ~630 representatives ~68K MDD and Alzheimer’s disease agitation STRONG MARKET ACCESS Medicare and Commercial lives 100% Medicaid lives 78% covered covered 15 © Axsome Therapeutics, Inc.
Slide 16: Launch readiness
Launch readiness Educational efforts across community and long -term care settings Broad insurance coverage and comprehensive patient support Commercial launch anticipated in approximately one month 16 © Axsome Therapeutics, Inc.
Slide 17: Alzheimer's Disease Agitation
Alzheimer’s Disease Agitation Jeffrey Cummings, MD, ScD Chambers -Grundy Professor of Brain Sciences, UNLV Kirk Kerkorian School of Medicine 17
Slide 18: Agitation is a common behavioral symptom across stages of Alzheimer's disease
Agitation is a common behavioral symptom that may present across multiple stages of Alzheimer’s disease Agitation encompasses three broadly defined symptom domains including both non -aggressive and aggressive behaviors 1,2 Excessive motor activity Verbal aggression Physical aggression • Pacing • Re
Slide 19: The CMAI questionnaire assesses a broad range of agitated behaviors
The CMAI questionnaire assesses a broad range of agitated behaviors consistent with the four IPA criteria Cohen -Mansfield Agitation Inventory (CMAI) 1 29 agitated behaviors organized into four subscales Individual agitated behavior scores Frequency of each behavior is rated on a 7 -point scale Phys
Slide 20: Agitation is among the most prevalent and distressing neuropsychiatric symptoms of Alzheimer's
Agitation is among the most prevalent and distressing neuropsychiatric symptom of Alzheimer’s disease Alzheimer’s disease agitation is associated with serious negative patient >7M outcomes… people in the U.S. live with Alzheimer’s disease, projected to double in the coming decades 1 Accelerated Func
Slide 21: Alzheimer's disease agitation treatment landscape
Alzheimer’s disease agitation treatment landscape Agitation affects the majority of patients with Alzheimer’s disease and is one of the most troubling and consequential aspects of Alzheimer’s disease for patients and caregivers 1,2 Historical pharmacologic treatments have been Limitations of off -la
Slide 22: AUVELITY in Alzheimer's disease agitation conclusions
AUVELITY in Alzheimer’s disease agitation conclusions 1 Unmet Need 2 Novel Mechanism 3 Clinical Results • Agitation is a highly • AUVELITY targets NMDA AUVELITY studies showed: prevalent and debilitating and sigma -1 receptors that • Significant reduction in symptom of Alzheimer’s modulate glutamate
Slide 23: Closing Remarks
Closing Remarks Herriot Tabuteau, MD Chief Executive Officer 23
Slide 24: A singular CNS platform
A singular CNS platform 3 4 Singular marketed products approved indications pipeline MDD 21M+ 6 novel product candidates AADAD 5M+ EDS in OSA or narcolepsy 22M+ 10 high -unmet -need indications Migraine 39M+ 24 © Axsome Therapeutics, Inc.
Slide 25: Leading neuroscience pipeline with deep stratification
Psychiatry Neurology Leading neuroscience pipeline with deep stratification Phase 1 Phase 2 Phase 3 NDA AXS -05 NMDA antagonist and Smoking Cessation (dextromethorphan -bupropion) sigma -1 agonist ADHD Binge Eating Disorder Solriamfetol DNRI and TAAR1 agonist MDD with EDS Shift Work Disorder AXS -12
Slide 26: Advancing the frontiers of brain health
Broad commercial portfolio Three innovative medicines improving patient outcomes and driving durable growth Advancing the frontiers Expanding AUVELITY of brain health Second approved indication expanding reach and accelerating growth Industry -leading CNS pipeline Potential first -in-class, best -in
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